Alimera Sciences, Inc., (Nasdaq:ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that the Company's New Drug Application (NDA) for Iluvien® (fluocinolone acetonide intravitreal insert) has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA). Iluvien is Alimera's investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).
FDA Priority Review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists. This status accelerates the standard review time from 10 months to six months. With priority review, Alimera could receive a response from the FDA in the fourth quarter regarding its NDA for Iluvien, which was submitted at the end of June 2010.
"Receiving Priority Review status from the FDA marks another important milestone in our efforts to provide an approved therapeutic option to DME patients," said Dan Myers, president and CEO of Alimera Sciences. "If approved, we believe that Iluvien will be the first pharmaceutical in the U.S. indicated to treat this disease, and the first long-term treatment with the potential to be therapeutically effective for up to 36 months."
Alimera is currently conducting two Phase 3 pivotal clinical trials (collectively known as the FAME Study) for Iluvien involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of Iluvien with two doses, a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study is the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study will conclude later this year with the final patient visits at the three-year data point.
Following its NDA submission to the FDA, Alimera submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain. The company expects to file in Canada in September. Based upon the analysis of the FAME Study, all filings include the 24-month low dose data only.
Research suggests no need for yellow fever vaccine booster after initial dose